A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 3 Study

Phase 3

Completed

Interventions: Drug: Timolol Maleate Ophthalmic Solution 0.5%
Drug: DE-117 Ophthalmic Solution

Brief Summary: This is a Phase III, randomized, double-masked, active-controlled, parallel-group, multi-center study. Subjects diagnosed with glaucoma or OHT who meet eligibility criteria at Visit 1 (Screening) will washout of their current topical IOP-lowering medication(s), if any. After completing the required washout period, subjects will return for Visit 2 (Baseline, Day 1). Subjects who meet all eligibility criteria at baseline will be randomized to receive double-masked treatment for 3 months. Adult subjects will receive open-label DE-117 Ophthalmic Solution for an additional 9 months.

Approximately 400 adult subjects and up to 30 pediatric subjects with glaucoma or OHT who meet all eligibility criteria will be randomized in a 1:1 ratio to receive either:

* DE-117 Ophthalmic Solution once daily and Vehicle once daily, or

* Timolol Maleate Ophthalmic Solution 0.5% twice daily. The study will evaluate the efficacy and safety of DE-117 Ophthalmic Solution compared with Timolol Maleate Ophthalmic Solution 0.5% in subjects with glaucoma or OHT through Month 3 and will provide additional safety data through Month 12 for subjects receiving DE-117.

Recruitment & Eligibility

Inclusion Criteria

• glaucoma or ocular hypertension

Exclusion Criteria

Females who are pregnant, nursing, or planning a pregnancy
Any corneal abnormality or other condition interfering with or preventing reliable tonometric measurements

Arm && Interventions

Group	Intervention	Description
Timolol Maleate Ophthalmic Solution 0.5%	Timolol Maleate Ophthalmic Solution 0.5%	Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only
DE-117 Ophthalmic Solution	DE-117 Ophthalmic Solution	Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure at Week 6	08:00, 10:00 and 16:00 at Week 6	Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day. Analysis using Mixed-Effects Model for Repeated Measures (MMRM)
Intraocular Pressure at Month 3	08:00, 10:00 and 16:00 at Month 3	Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day. Analysis using Mixed-Effects Model for Repeated Measures (MMRM)
Intraocular Pressure at Week 1	08:00, 10:00 and 16:00 at Week 1	Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day. Analysis using Mixed-Effects Model for Repeated Measures (MMRM)

Secondary Outcome Measures

Name	Time	Method
Mean Diurnal Intraocular Pressure (IOP) at Month 3 (First Key Secondary Endpoint)	Month 3	Mean Diurnal Intraocular Pressure (IOP) at Month 3: Analysis using Mixed-Effects Model for Repeated Measures (MMRM) on observed cases.
Intraocular Pressure (IOP) at Week 1 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint)	08:00, 10:00 and 16:00 at Week 1	Intraocular Pressure (IOP) at Week 1 with baseline mean diurnal IOP less than 25 mmHg (Second Key Secondary Endpoint)
Intraocular Pressure (IOP) at Month 3 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint)	08:00, 10:00 and 16:00 at Month 3	Intraocular Pressure (IOP) at Month 3 with baseline mean diurnal IOP less than 25 mmHg (Second Key Secondary Endpoint)
Mean Diurnal Intraocular Pressure (IOP) at Week 1 (Third Key Secondary Endpoint)	Week 1	Mean Diurnal Intraocular Pressure (IOP) at Week 1: Analysis using Mixed-Effects Model for Repeated Measures (MMRM) on observed cases. Mean Diurnal IOP at week 1 is defined as the average IOP of all three timepoints (8AM, 10AM and 4PM) at week 1.
Intraocular Pressure (IOP) at Week 6 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint)	08:00, 10:00 and 16:00 at Week 6	Intraocular Pressure (IOP) at Week 6 with baseline mean diurnal IOP less than 25 mmHg (Second Key Secondary Endpoint)

Locations (47): Arizona Glaucoma Specialists
🇺🇸
Phoenix, Arizona, United States
DocTrials Walman Eye Center
🇺🇸
Sun City, Arizona, United States
Havana Research Institute
🇺🇸
Burbank, California, United States
Macy Eye Center
🇺🇸
Los Angeles, California, United States
North Valley Eye Medical Group
🇺🇸
Mission Hills, California, United States
North Bay Eye Associates, Inc
🇺🇸
Petaluma, California, United States
Martel Eye Medical Group
🇺🇸
Rancho Cordova, California, United States
Samsum Clinic (DocTrials)
🇺🇸
Santa Barbara, California, United States
MCB Clinical Research Centers LLC
🇺🇸
Colorado Springs, Colorado, United States
Hernando Eye Institute
🇺🇸
Brooksville, Florida, United States
Scroll for more (37 remaining)
Arizona Glaucoma Specialists
🇺🇸Phoenix, Arizona, United States